Working Memory Training for Chronic Neuropathic and Fibromyalgia Pain

Fibromyalgia Clinical Trial

— NEPA  

Official title:

Executive Control, Processing Speed and Memory Function in Long- Term Peripheral Neuropathic Pain and Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02824588
• Other study ID #: 2016/8442
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: September 2, 2018

Study information

• Verified date: September 2018
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this project is to investigate and improve executive control function in two distinct pain conditions, namely neuropathic pain and fibromyalgia (FM). It is hypothesized that there is a significant difference in the executive control function of patients with neuropathic pain and FM pain. It is also hypothesized that all participants with poor executive control functioning will report significant improvements in pain intensity, functioning and cognitive complaints following cognitive training. The study tests and influence the working memory concepts of inhibition, updating and flexibility through an experimental, cross-over treatment design.

To perform the experiment, we will recruit 160 participants (80 with neuropathic pain and 80 with FM) from the Departments of pain management and research at St Olav's University Hospital and Oslo University Hospital (OUS). The proposed design will be able to determine whether or not executive control, processing speed and memory function differs in two distinct populations of pain patients. Moreover, whether impairments are amended by computerized training.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: September 2, 2018
• Est. primary completion date: September 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of fibromyalgia or neuropathic pain

• Confirmed objective cognitive impairments on the CANTAB battery compared to IQ control

Exclusion Criteria:

• Mania, suicidal ideation and/or active psychosis

• No objective cognitive impairments

• Personality disorders

• Pregnancy

Related Conditions & MeSH terms

• Fibromyalgia
• Memory Disorders
• Myofascial Pain Syndromes
• Neuralgia
• Neuropathic Pain
• Working Memory Deficits

Intervention

Behavioral:
• Working Memory Training
Training mental flexibility
• Internet use
Used as control for time spent on computer

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective neuropsychological tests	CANTAB test battery	36 weeks
Secondary	Pain intensity	VAS scale	36 weeks
Secondary	Stress regulation	Hair cortisol	36 weeks
Secondary	Symptoms of depression	Hopkins symptom checklist	36 weeks
Secondary	Sleep duration, quality and awakening	Actigraphy	36 weeks
Secondary	Quality of life	EQ-5D	36 weeks
Secondary	Medication use	Registered analgetic usage	36 weeks
Secondary	Self-reported memory and concentration impairments	Everyday Memory Questionnaire	36 weeks
Secondary	Self-reported cognitive intrusion	Questionnaire	36 weeks